Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive Quizartinib

NCT03746912 | Unknown

• 1 other identifier: AC220-A-U203
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

An expanded access program (EAP):

• Allows doctors to give medicine to patients,
• Before it is approved by health authorities. This EAP is for:
• Quizartinib
• Patients with FLT3-ITD mutated AML,
• AML that has come back, or
• Is resistant to other therapies. A participant will receive quizartinib if:
• The doctor submits a request,
• The participant is eligible, and
• The country allows the EAP.

Conditions

Acute Myeloid Leukemia With Gene Mutations

Keywords

Refractory or Relapsed; FLT3- internal tandem duplication (ITD) mutation; FLT3-ITD mutation

Interventions

Quizartinib Dihydrochloride DRUG

Tablets for once daily oral administration at doctor-recommended dose in continuous 28-day cycles

Also known as: Quizartinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided written informed consent as approved per local regulations with privacy language in accordance with national regulations (eg, Health Insurance Portability and Accountability Act \[HIPAA\] authorization for US sites) prior to any protocol-related procedures
• Is 18 years of age or the minimum legal adult age (whichever is greater) at the time of informed consent
• Has morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS) or other myeloproliferative neoplasms (MPN), as defined by the World Health Organization (WHO) 2008 classification with ≥5% blasts in bone marrow, with or without extramedullary disease
• Is in relapse or refractory (R/R) to prior therapy, with or without HSCT
• Refractory is defined as:
• participant did not achieve complete remission (CR), CR with incomplete platelet recovery (CRp), or CR with incomplete hematological recovery (CRi) under initial intensive therapy, or
• did not achieve CR, CRp, CRi, or partial remission (PR) under initial sufficient time course of treatment with hypomethylating agents or low-dose cytarabine (LoDAC)
• must have received at least one complete block of induction therapy seen as the optimum choice of therapy to induce remission or at least 4 cycles of therapy with a hypomethylating agent deemed sufficient to induce a response
• Relapse is defined as: relapse diagnosed by bone marrow assessment or by the appearance of peripheral blasts after the achievement of CR, CRp, or CRi, as defined by 2003 International Working Group criteria after AML therapy with or without consolidation or maintenance, and with or without HSCT
• Has documented FLT3-ITD mutation in bone marrow or peripheral blood in relation R/R disease
• Prior treatment with kinase inhibitors, including FLT3 targeted therapy or investigational FLT3 inhibitors is allowed
• Has an Eastern Cooperative Oncology Group (ECOG) performance score 0-3
• Discontinued prior AML treatment before the start of protocol treatment (except hydroxyurea or other treatment to control leukocytosis) for at least 2 weeks for cytotoxic agents, or for at least 5 half-lives for non-cytotoxic agents
• Has creatinine clearance \>25 mL/min, as calculated with the Cockcroft-Gault formula
• Has serum potassium, magnesium, and calcium (serum calcium corrected for hypoalbuminemia) within institutional normal limits. Participants with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation

You may not qualify if:

• Participants who meet any of the following criteria will be disqualified from enrollment:
• Is eligible to enroll in a recruiting clinical trial of quizartinib or is currently enrolled in an ongoing clinical trial of quizartinib
• Has previously participated in a randomized clinical study of quizartinib with an endpoint of survival that is not closed for efficacy
• Has acute promyelocytic leukemia (AML subtype M3)
• Has persistent, clinically significant ≥Grade 3 non-hematologic toxicity from prior AML therapy
• Has clinically significant acute graft-versus-host disease (GvHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or ≥Grade 3 persistent or clinically significant non-hematologic toxicity related to HSCT
• Has uncontrolled or significant cardiovascular disease, including:
• QTcF interval \>450 ms
• Bradycardia of less than 50 beats per minute (bpm) unless the patient has a pacemaker
• Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome
• History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes
• History of second or third degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers.
• Myocardial infarction within 6 months prior to screening
• Uncontrolled angina pectoris within 6 months prior to Screening
• New York Heart Association (NYHA) Class 3 or 4 congestive heart failure

Sponsors & Collaborators

• Daiichi Sankyo: lead

MeSH Terms

Conditions

Recurrence

Interventions

quizartinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 20, 2018
• Last Updated: April 15, 2020

Record last verified: 2020-04